FDA.reportPublic FDA data

betr remedies ibuprofen

Product NDC
80267-999
11-digit product format
802670999
Labeler code
80267
Product ID
80267-999_0a50820f-1dfa-45b5-824f-2c28822fc6c6
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Live Betr LLC
Application
ANDA072096
Marketing category
ANDA
Marketing start
2023-07-26
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
betr remedies ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80267-999-78betr remedies ibuprofen1 in 1 CARTONTABLET, FILM COATED11
80267-999-78betr remedies ibuprofen100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80267-999BETR REMEDIES IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [LIVE BETR LLC]1Current NDC, 2 package rows20230811_0a50820f-1dfa-45b5-824f-2c28822fc6c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN0a50820f-1dfa-45b5-824f-2c28822fc6c61
310965ibuprofen 200 MG Oral TabletSCD0a50820f-1dfa-45b5-824f-2c28822fc6c61
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY0a50820f-1dfa-45b5-824f-2c28822fc6c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80267-999-78802670999781 BOTTLE in 1 CARTON (80267-999-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-07-26NoNoHistorical